Recall Z-1836-2020— Radiometer Medical ApS
Class II · Ongoing
Class II FDA medical device recall by Radiometer Medical ApS, initiated 2020-03-06. It names one FDA 510(k) clearance: K041874. Product: ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004. Reason: Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function..
- Recalling firm
- Radiometer Medical ApS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-03-06
- Firm location
- Bronshoj, N/A, Denmark
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Reason for recall
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
Data sourced from openFDA. This site is unofficial and independent of the FDA.